NCT05850689 · Intra-Cellular Therapies, Inc.
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
What this study is about
This is a conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
View original scientific description
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Interventions
DRUG
Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
DRUG
Placebo
Matching capsules administered orally, once daily
Primary outcome measures
Montgomery-Asberg Depression Rating Scale
Time frame: Day 43
The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female patients between the ages of 18 and 65 years, inclusive; 2. Meets DSM-5 criteria for MDD (MDD with psychotic features will be acceptable) as confirmed by the Investigator or Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and meets all of the following criteria: 1. The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening; 2. Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline; 3. Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline; 4. Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline; 5. Has sufficient history and medical record confirmation verifying the ADT and the current MDE is causing clinically significant
Where
- Huntsville, Alabama
- Pico Rivera, California
- Farmington, Connecticut
- Clermont, Florida
- Hialeah, Florida
- Miami, Florida
- Tampa, Florida
- Atlanta, Georgia
- Decatur, Georgia
- Kansas City, Kansas
- Overland Park, Kansas
- Methuen, Massachusetts
And 12 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations